Director of Quality Assurance

Performing critical work that impacts our industry and our world’s health while problem solving and innovating in the field – that is what the Director of Quality Assurance at KCAS Bio gets to do every day. If that gets you excited too, then maybe working as the Director of Quality Assurance is the role for you. When you work as a Director of Quality Assurance at KCAS Bio, you have the opportunity to further our mission at the core by managing one or more QA departments or groups staffed by professional employees performing quality assurance functions and interacting with executive management, clients, and regulatory agencies as needed regarding quality systems, audits, and inspections. You will be responsible for maintaining a high-level of professional expertise and leading regulatory inspections during FDA and critical client audits, overseeing the quality management system maintained at KCAS Bio, and providing expertise and guidance to all departments for interpreting and implementing health agency regulatory requirements. While managing these responsibilities, you will also oversee the quality management system currently supported at KCAS Bio, meet department goals and objectives, and serve as a member of the Senior Leadership Team. In this role, we will rely on you to:

Assure Quality systems are designed and performing to meet industry, regulatory and executive management requirements

Initiate employee hire, promotion, discharge, or transfer

Participate in the selection process for subordinate personnel including determining recruiting criteria, interviewing, and performing reference checks

Perform annual performance evaluations for direct reports

Require and monitor training for subordinates to develop them to their potential

Effectively use delegation to develop subordinates

Perform career planning for subordinates

Provide encouragement and positive reinforcement to subordinates; require subordinate leadership staff to do the same

Participate in the development of short and long-range goals and objectives, implement and attain short and long-range goals and objectives, and assure that year-end goals are attained

Assure that all departmental management staff are working in concert with each other

Coordinate activities of the department with related activities of other departments, to ensure efficiency and economy

Understand, communicate and cascade communication from Executive management

Be knowledgeable of site departmental budget and will monitor and analyze cost against budget

Overall responsibility for the Quality Assurance operation, compliance and site department goals including budget management

Interact with clients relating to quality audits, respond to client audit reports, and understand client needs/expectations

Complete client QA questionnaires and respective QA-assigned sections of RFIs

Forecast, recommend and justify strategies to accommodate growth when needed (space, equipment, staffing)

Establish policies and procedures to ensure that QA operations maintain a high level of QA expertise, remains abreast of current technologies and complies with related regulatory policies, OSHA and company SOPs/policies

Audit reports, data, internal processes, computer system validations, facility, and procedures to support management to improve data integrity, reduce error rates, efficiency, and maintain compliance

Manage internal auditing program including planning, conduct and reporting of audits

Conduct annual management review of the quality system

Manage digital quality systems, including eQMS administration, archiving, and related scanning

Ensure appropriate validation of methodology and instrumentation per regulatory requirement/industry expectation

Oversee CAPA system to ensure effective continuous improvement. Designates a CAPA

Coordinator and back-up within the department

Perform and track vendor quality assessments

Review/update SOPs to reflect current practice and regulatory requirements

Maintain expert knowledge of bioanalytical scientific trends as well as regulatory requirements

Perform complex quality assignments with understanding of underlying scientific principles

Recommend and institute systems and programs to improve safety, work quality, cost saving and productivity

Effectively interface with various functional units, groups or departments in the company

To qualify specifically for this role, you will have:

Bachelor’s degree in a related field

Director-level experience preferred

10 years industry-related experience, including 2 years supervisory experience

Experience in a CRO or pharmaceutical company is preferred

Broad knowledge of regulatory requirements applicable to areas managed

Extensive knowledge of processes applicable to subordinate groups

Awareness of industry trends related to areas managed

Computer proficiency

Perform all aspects of the job in a way that supports the company brand and the company mission, vision, and values